Frank Willford Email & Phone Number

Raleigh, Nc, Us

Waltham, Ma, Us

Validation of a new downstream single-use chromatography skid to support Thermo Fisher's CMO organization and for commercial clients. Provide subject matter expertise to design and lead validation/qualification of a strategic new pharmaceutical introduction.

Springville, Utah, Us

Fostering and developing a more robust company-wide equipment qualification and process validation program. Generates necessary documentation that pertains to the qualification of equipment and critical utilities. Coordinating the scheduling of validation protocol executions and testing with company Departments and personnel.

Burlington, Ma, Us

Responsible for capital project life cycles including initiation, managing scope, budgeting, procurement of contractors, materials & equipment, scheduling, and closure documentation. Lead capital projects for fire suppression systems, manufacturing equipment, and other instruments necessary to support chemical processing and contract manufacturing.Conduct fire suppression upgrades for powered buffers manufacturing, small equipment, and other instruments needed to support any contract manufacturing.• Manage the commissioning, validation, and closeout for Clean-in-Place (CIP) pump skids, compact vertical foil packaging machines (tablet packagers), powder transfer systems, and Clean-Out-of-Place (COP) skids.

Whitsett, North Carolina, Us

Prepared project plans with milestones and timelines using the GAMP V-Method as a model. Authored qualification documents including a URS/FRS/DS document, OQ protocol and a traceability matrix.• Facilitated upgrades to gelatin capsule manufacturing by leading the qualification and validation of InfinityQS ProFicient Statistical Process Control (SPC) software that monitored viscosity of liquid gelatin.

Philadelphia, Pa, Us

Contracted by Novartis Vaccines to provide engineering support for the process qualification and validation of a new Quadri-valent seasonal flu vaccine to meet market demand. • Expedited the process development, qualification, and validation of the bulk downstream purification process and final formulation in support of the monovalent pandemic H5N1 for Phase III clinical trials and H7N1 bulk drug substances and initial site licensure for the trivalent seasonal flu vaccine.

Led technology transfer of a critical viral vaccine stabilizing buffer. Conducted engineering batch, managed change control, developed processing procedures, and set process parameters to maintain Critical Quality Attributes (CQAs).• Developed a re-dispense process for intermediate stock solutions. Worked with operations, technology, and quality departments to implement new processes in a bulk manufacturing facility.

New York, New York, Us

Worked on new process development, validation, and regulatory submission. Provided engineering support and project management assistance on the design, development, validation, and regulatory submission of a new disposable closed-system sterile filling process that saved $50 million in facility capital upgrades and fulfilled an international regulatory commitment. Assisted the project manager with developing plans, estimating a capital budget and establishing a cross-functional team to develop major milestones and timelines. Worked with outside vendors and manufacturing personnel to design a disposable closed system filling process.• Supported the technology transfer of a product storage container integrity test which reduced product loss by more than 50%. Support included identifying and purchasing equipment, planning and executing engineering studies, analyzing data using JMP statistical software and establishing integrity testing parameters and procedures.• Collaborated with research & development on the use of an optically-based dissolved oxygen probe to control microbial fermentation batches. Designed and executed Design of Experiments (DoE) studies to determine the robustness of newly dissolved oxygen probes and optimal fermentation parameters.

Pearl River, Ny, Us

Launched process and equipment improvement projects and pilot scale process development.• Collaborated with manufacturing departments and support groups to implement equipment and procedure improvements to ensure a plentiful, consistent, and reliable supply of vaccines. Improvements reduced product losses by $60 million within the first two years of implementation.• Led a scaled-down purification operation for a 13-valent Prevnar vaccine process to ensure a more efficient polysaccharide production. Trained and coached employees in ultra & depth filtration, diafiltration, HA ion exchange, chromatography, and 0.22pm sterile filtration unit operations. Assisted with the development of polysaccharide fermentation and centrifugation processes.

Troy, Michigan, Us

Manufacturing Process Development

Four years experience in solid and hazardous waste management, RCRA and CERCLA investigation, environmental engineering analysis and federal environmental regulation.